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Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) - Based Planning and Creation of Orthodontic Appliances

NCT ID: NCT00871026

Last Updated: 2009-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2010-10-31

Brief Summary

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In orthodontics, conventional fixed appliances, usually consisting of prefabricated components, require step-by-step adjustment in order to move teeth in the planned direction.

May treatment be improved with customized archwires?

Study hypotheses:

* By using CAD/CAM in planning and fabrication of customized archwires, unnecessary tooth movements can be avoided and teeth can be moved on their direct path to the intended position.
* The application of CAD/CAM improves reproducibility, efficiency, and quality of orthodontic treatment.

Detailed Description

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In orthodontics, conventional fixed appliances, usually consisting of prefabricated components, require step-by-step adjustment in order to move teeth in the planned direction. At the moment there is no tool, that allows to predict the treatment result. Using conventional orthodontic treatment methods the orthodontist approaches the final result using the trial-and-error-method, bending the wires in each appointment until both, patient and orthodontist are satisfied. Usually there is only a general treatment plan, but not a detailed treatment plan of each tooth movement. This leads to a longer treatment time and causes more costs. Besides the probability of side effects (such as caries root resorption) increases with the duration of the treatment.

In this case the chosen technology is called SureSmile(R)(by OraMetrix). SureSmile allows the collection 3D-data intraorally and from plaster models, it gives a possibility of computer aided treatment planing (Computer Aided Design) and the manufacturing of customized archwires (Computer Aided Manufacturing).

This new technology promises to reduce the time and effort of an orthodontic treatment providing predictability and quality also minimizing negative side effects.

This technology could - using this diagnostic 3D-system - help to understand orthodontic movement and basic principles of the remodeling of the periodontium and to improve orthodontic mechanics.

Conditions

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Orthodontics

Keywords

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CAD/CAM orthodontics fixed appliance tooth movement Adverse Effects Time Factors Treatment Outcome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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1

CAD/CAM group, customized archwires

Group Type EXPERIMENTAL

orthodontic treatment with customized archwires

Intervention Type PROCEDURE

orthodontic treatment with customized archwires

2

prefabricated archwires (superelastic)

Group Type ACTIVE_COMPARATOR

orthodontic treatment with prefabricated archwires

Intervention Type PROCEDURE

orthodontic treatment with prefabricated archwires

Interventions

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orthodontic treatment with customized archwires

orthodontic treatment with customized archwires

Intervention Type PROCEDURE

orthodontic treatment with prefabricated archwires

orthodontic treatment with prefabricated archwires

Intervention Type PROCEDURE

Other Intervention Names

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SureSmile, CAD/CAM prefabricated archwires, conventional orthodontics

Eligibility Criteria

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Inclusion Criteria

* treatment with fixed orthodontic appliances is indicated
* complete secondary dentition
* age: 11-30
* in good general health
* patient is informed about study and agrees to participate

Exclusion Criteria

* syndromes affecting bones and teeth
* cleft lip and palate
* inflammation or reduction (more than 50%) of periodontium
* intake of drugs affecting tooth movement and bone formation
* disturbance of bone formation
* disturbance of thyroidal function
* pregnancy
* participation in additional study affecting oral hygiene
* former therapy with ionized radiation or cytostatic drugs
* caries (active phase)
* alcohol dependency
Minimum Eligible Age

11 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Charité - Universitätsmedizin Berlin

Principal Investigators

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Paul-Georg Jost-Brinkmann, Prof

Role: STUDY_CHAIR

Charite - Universitätsmedizin

Locations

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Department of Orthodontics, Dentofacial Orthopedics and Pedodontics, Charité - Universitätsmedizin Berlin

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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JO 207/4-1-5

Identifier Type: -

Identifier Source: org_study_id